SERACH RESULTS FOR" Development "
Development / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure successful cGMP manufacturing operations. We remain committed to providing support for the production of high-quality biopharmaceutical products through optimized operating systems and processes.Analytical Testing CapabilitiesAcross the manufacturing process, our QC team performs testing on samples including raw materials, in-process, DS/DP release, and stability.Our QC team is capable of performing analytical test method transfers from client laboratories, method validation, qualification, and verification in accordance to ICH Q2 (R1) guidelines, FDA, EMA, and PMDA requirements.Our QC scientists provide their expertise based on the extensive experience they have acquired in GMP laboratory environments, and the use of validated cutting-edge equipment. The following are examples of some of the analytical test methods that our QC team is capable of:Chemical Testing1. Impurity / Purity by HPLC2. Identification by FT-IR3. Water content4. Osmolality, Protein Content (A280), Appearance, pHBiochemical Testing1. Polymerase Chain Reaction (PCR)2. Enzyme-Linked Immunosorbent Assay (ELISA)3. Electrophoresis (gel-based / capillary electrophoresis)4. Cell-Based AssaysMicrobiological Testing1. Sterility2. Microbial Limit (Bioburden)3. Microbial Identification4. EndotoxinStability Program CapabilitiesWe maintain controlled areas that have validated and monitored stability chambers suitable for the collection of GMP Drug Product/Drug Substance stability data. The physical and kinetic stability profiles are generated with real-time storage conditions and accelerated conditions (with temperature and/or light).Environmental and Clean Utility MonitoringThrough our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), QC guarantees that our controlled environments are maintained for the manufacturing of high-quality products. All analyses are performed under strict cGMP requirements. Environmental Monitoring includes the testing for Viable / Non-viable air particles and surfaces. Clean Utilities Monitoring includes the testing of water, compress gases, and clean steam for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.
development stage to DS products for lot release tests of Mycoplasma & Virus detection. Our service is expanding to Cell bank manufacturing, Cell line characterization and Viral clearance study. Overview imageSamsung Biologics CRO?Lot Release TestingMycoplasma & Virus detection, Sterility, Endotoxinand Bioburden testingCell Line CharacterizationIdentity (NGS), In vitro / In vivo virus screen,Adventitious, Retrovirus and mycoplasma testingCell Bank ManufacturingMCB / WCB / EOPC manufacturing andcell storage servicesViral ClearanceVirus inactivation and removal study (GLP)
Development Finishing Fully Automated Visual Inspection Secondary Bulk Packaging Storage& Shipping 2-8 ℃ to -70 ℃ Storage Options Passive and Active Shipping Options Regulatory Support Approved in over 20 Global Markets Type V DMFFull CMC end-to- end support 1 / 5 Client Satisfaction We are committed to Re-inventing the Client Experience in the DP CMO world. From the first point of contact,we are committed to ensuring you have the most pleasant experience possible. We know Tech Transfers, Clinical Trials and Commercial Operations can be very difficult and daunting; we are here to help you simplify and succeed in your program objectives. We’ll make it easy on you and your team just the way it should be. Speed to Market We live in an industry where mere days can make the difference between a blockbustersuccess or a complete program implosion. We are confident that you’ll find our expertise in development, tech transfer and commercialization to be the missing link to achieving your goals. Our entire facility is designed around the intention to get your product to market faster and better.On Time, In Full; every time, all the time. Adaptability Whether you are moving your product from the benchtop or from another facility around the world, don’t worry.We can help. Our facility and systems have been designed to be able to adapt to the many nuances and requirements of our strict industry. Our staff of seasoned experts and well appointed facilities are ready and able to take on nearly every challenge keeping you awake at night. If we don’t have it, we’ll work with you to design the system or purchase the equipment to ensure your success. We are here to serve you and your patients. pause
development & manufacturing of your product. We are committed to operational excellence in cGMP manufacturing and quality assurance to deliver value to our clients. Samsung Biologics' Values for Customer SatisfactionFully integrated CDMOservice offerings at a singlemanufacturing complexDedicated projectmanagement to overseethe whole lifecycleRegulatory supportwith strong IP protectionCompetitive pricing &flexible business termsOn time,in full deliveryClinical ProductionEarly clinical material production involves a number of risks and uncertainties. We are committed to provide precisely tailored solutions to mitigate such risk, with our strong drug development capability and flexible capacities. CommercialProductionThe market dynamics of rising competition in biologics require drug developers to devote considerable efforts to be more methodical and cost-effective in manufacturing. Samsung Biologics is able to achieve fast turnaround with economy of scale to deliver high-quality products to market, on time. Aseptic FillingSterile filling is one of the most critical steps in the drug manufacturing process relative to overall patient and product safety. Our clinical and commercial fill/finish services ensure you are consistently supplied with the highest possible quality, everytime, all the time.
Development Right Start,and BetterQualityAt Samsung Biologics, we provide high-quality mammalian cell line development for a variety of antibodies and proteins using the CHOZN platform. Along with Samsung Biologics’ specialized cell line development know-how, our experts have extensive experience of molecule development including difficult-to-handle products and are capable of delivering robust, high-yield single cell clone to our clients. Process image
Development ThroughCutting-EdgeTechnologyCell line development completes within 3 months generating high quality,high titer clones High titer of ~ 5g/L (mAb) results in cost saving in later stage of productionLower lifetime costs through flexible licensing/pricing terms and no royaltyafter commercializationTiter and timeline are estimated based on past performance but may differ depending on client’s specific molecule and project requirementsTiter subject to project detailsSingle Cell Cloning With Beacon ®Single cell cloning with Beacon TM imageex-pression vectortransfection9pools + minipoolstiter + cqa6 weeks / (growth profile, productivity and product quality)6800 clones7 weeks / (growth profile, productivity and product quality)24~28 clonestop 10top 3 rcbBerkeley ®Light Beaconfully automated live cell isolation, selection, and screening in nanopens Screen 5,000 individual cells to find the best secretorsEfficient down selection on unstable clonesAutomated monoclonality process with visual record at > 99% Beacon is a registered trademark of Berkeley Lights, Inc. Berkeley Light Beacon image
DevelopmentPath fromGene to INDAt Samsung Biologics, our development experts generate and optimize scalable, robust process for reliable support of our clients’ clinical and long-term commercial supply.Our services include the development of cell lines, upstream and downstream processes, analytical methods and formulations.We connect all aspects of development to clinical and commercial production to form an integrated process. From Gene to INDFrom Gene to IND image
development & Manufacturingservice (Cell Line Development - DS, DP Manufacturing - IND filling)Competitive Pricing- No binding Structure, no royalty payment- Competitive pricing with the best qualityExcellent Quality & Capability- mAb titer of 11.6g/L, Bispecific titer of 4+g/L- Faster, Tailored timeline available- 51+ global regulatory approvalsMaximum Client Satisfaction- Dedicated project management to ensure successful Project ution- Increase customer’s value from faster timeline, high quality & better pricing
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Samsung Biologics Confirms 'No Impact' of COVID-19 with Business Continuity Plan in EffectFebruary 25, 2020
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